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Hydroxypropyl Betadex BP/USP/EP
Date of Issue : 2022-07-08
Valid Till : 2024-11-04
Written Confirmation Number : WC-0432
Address of the Firm : Plot No N·5, MIDC, Boisar, Tal Palghar, Dist- Thane, 401506, Maharashtra
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A Hydroxypropyl-Beta Cyclodextrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxypropyl-Beta Cyclodextrin, including repackagers and relabelers. The FDA regulates Hydroxypropyl-Beta Cyclodextrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxypropyl-Beta Cyclodextrin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Hydroxypropyl-Beta Cyclodextrin supplier is an individual or a company that provides Hydroxypropyl-Beta Cyclodextrin active pharmaceutical ingredient (API) or Hydroxypropyl-Beta Cyclodextrin finished formulations upon request. The Hydroxypropyl-Beta Cyclodextrin suppliers may include Hydroxypropyl-Beta Cyclodextrin API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxypropyl-Beta Cyclodextrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxypropyl-Beta Cyclodextrin active pharmaceutical ingredient (API) in detail. Different forms of Hydroxypropyl-Beta Cyclodextrin DMFs exist exist since differing nations have different regulations, such as Hydroxypropyl-Beta Cyclodextrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxypropyl-Beta Cyclodextrin DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxypropyl-Beta Cyclodextrin USDMF includes data on Hydroxypropyl-Beta Cyclodextrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxypropyl-Beta Cyclodextrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with USDMF on PharmaCompass.
A Hydroxypropyl-Beta Cyclodextrin CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxypropyl-Beta Cyclodextrin Certificate of Suitability (COS). The purpose of a Hydroxypropyl-Beta Cyclodextrin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxypropyl-Beta Cyclodextrin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxypropyl-Beta Cyclodextrin to their clients by showing that a Hydroxypropyl-Beta Cyclodextrin CEP has been issued for it. The manufacturer submits a Hydroxypropyl-Beta Cyclodextrin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxypropyl-Beta Cyclodextrin CEP holder for the record. Additionally, the data presented in the Hydroxypropyl-Beta Cyclodextrin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxypropyl-Beta Cyclodextrin DMF.
A Hydroxypropyl-Beta Cyclodextrin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxypropyl-Beta Cyclodextrin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with CEP (COS) on PharmaCompass.
A Hydroxypropyl-Beta Cyclodextrin written confirmation (Hydroxypropyl-Beta Cyclodextrin WC) is an official document issued by a regulatory agency to a Hydroxypropyl-Beta Cyclodextrin manufacturer, verifying that the manufacturing facility of a Hydroxypropyl-Beta Cyclodextrin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydroxypropyl-Beta Cyclodextrin APIs or Hydroxypropyl-Beta Cyclodextrin finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydroxypropyl-Beta Cyclodextrin WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Hydroxypropyl-Beta Cyclodextrin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxypropyl-Beta Cyclodextrin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Hydroxypropyl-Beta Cyclodextrin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Hydroxypropyl-Beta Cyclodextrin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxypropyl-Beta Cyclodextrin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with NDC on PharmaCompass.
Hydroxypropyl-Beta Cyclodextrin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Hydroxypropyl-Beta Cyclodextrin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Hydroxypropyl-Beta Cyclodextrin GMP manufacturer or Hydroxypropyl-Beta Cyclodextrin GMP API supplier for your needs.
A Hydroxypropyl-Beta Cyclodextrin CoA (Certificate of Analysis) is a formal document that attests to Hydroxypropyl-Beta Cyclodextrin's compliance with Hydroxypropyl-Beta Cyclodextrin specifications and serves as a tool for batch-level quality control.
Hydroxypropyl-Beta Cyclodextrin CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxypropyl-Beta Cyclodextrin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Hydroxypropyl-Beta Cyclodextrin may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxypropyl-Beta Cyclodextrin EP), Hydroxypropyl-Beta Cyclodextrin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxypropyl-Beta Cyclodextrin USP).
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